A Comparative Study of the Effects of QS-M Needle Free Injector and Glargine Pen Subcutaneous Injection of Insulin Glargine on Insulin Use

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Comparative Study of the Effects of QS-M Needle Free Injector and Glargine Pen Subcutaneous Injection of Insulin Glargine on Insulin Use

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03420040
• Other study ID #: KY20172077-1
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 9, 2018
• Last updated: January 31, 2018
• Start date: November 27, 2017
• Est. completion date: April 1, 2018

Study information

• Verified date: December 2017
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A clinical study of the use of glargine insulin in 2 subjects with type two diabetes in China was carried out. The two kinds of injection methods were evaluated as subcutaneous injection of insulin glargine.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 65
• Est. completion date: April 1, 2018
• Est. primary completion date: February 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. male or female aged 18-70 years of age, women of childbearing age need to take adequate contraceptive measures to minimize the risk of pregnancy;

2. the standard of diagnosis of type 2 diabetes and the course of the disease is more than half a year;

3. 18 Kg/m2 = BMI = 30Kg/m2;

4. received daily injections of insulin glargine and also take one to three kinds of oral medicine (not including secretagogues) patients, daily insulin glargine total dose more than 12IU but <50IU, the use of insulin glargine than in January;

5. the blood glucose in the fasting vein was in 5.0-9.0mmol/L;

6. the letter of informed consent has been read and signed.

Exclusion Criteria:

1. there is conflict of interest with this research.

2. blood glucose control is not good enough to participate in this study, such as repeated hypoglycemia, diabetic ketoacidosis or hyperosmolar coma.

3. serious diabetic complications such as diabetic foot, diabetic nephropathy and so on;

4. severe cardiovascular events occurred in the last 6 months.

5. the application of hormone or immunosuppressant, or low immunity defect;

6. the use of non steroidal anti-inflammatory drugs;

7. the use of sulfonylureas and insulin secreting agents;

8. a person with a history of cancer;

9. a history of unstable or rapid progressive renal disease;

10. an unstable history of major mental illness;

11. the history of hemoglobin (such as sickle red cell anemia, thalassemia, iron granulocytic anemia);

12. women who are pregnant or are breastfeeding;

13. in the near future there is a clear infection, such as urinary tract infection and pneumonia;

14. recent important visceral hemorrhage, such as gastric hemorrhage and cerebral hemorrhage, etc.

15. skin diseases such as exfoliative dermatitis, pustular sore and infection of pyogenic bacteria;

16. the history of acute pancreatitis or pancreatectomy;

17. the researchers believe that it may lead to any situation in which the subject is unable to complete the study or may cause significant risk to the subject.

18. the results of the laboratory examination are as follows: A. obvious abnormal liver function or in the active phase of the disease (AST> 3 times the upper limit of normal ALT> or 3 times the upper limit of normal); The creatinine clearance rate of B. was <60ml/min; C. anaemia caused by any cause of the disease; The results of pregnancy test in women of childbearing age of D. were positive.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Device:
• QS-M Needle Free Injector
The subjects were proficient in the two injection methods of injection of QS-M needle free syringe and Glargine pen injection
• Glargine pen
The subjects were proficient in the two injection methods of injection of QS-M needle free syringe and Glargine pen injection

Locations

Country	Name	City	State
China	Xijing Hospital, Fourth Military Medical university	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in fasting blood glucose between baseline to week 4	fasting blood glucose are measured at baseline and week 4	baseline and week 4